Effects of Omega-3 Plus Low-dose Aspirin as Adjunct to Periodontal Debridement for Chronic Periodontitis in Diabetics

Diabetes Mellitus Clinical Trial

Official title:

Effects of Omega-3 Polyunsaturated Fatty Acids Daily Supplementation Plus Low-dose Aspirin as Adjunct to Full-mouth Periodontal Ultrasonic Debridement for the Treatment of Chronic Periodontitis in Type 2 Diabetics: Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02800252
• Other study ID #: NCSFOSJC
• Status: Recruiting
• Phase: N/A
• First received: June 10, 2016
• Last updated: November 22, 2016
• Start date: June 2016
• Est. completion date: December 2018

Study information

• Verified date: November 2016
• Source: Universidade Estadual Paulista Júlio de Mesquita Filho
• Contact: Nidia C Santos, MS
• Phone: 5512991021346
• Email: nidia.santos[@]ict.unesp.br
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Therefore, the aim of this study is to investigate the effectiveness of daily supplementation of omega-3 polyunsaturated fatty acids and low-dose aspirin as adjunct therapy to one-stage full-mouth periodontal ultrasonic debridement for the treatment of chronic periodontitis in type 2 diabetic patients through a superiority randomized clinical trial.

Description:

Diabetes mellitus (DM) has become a global epidemic. Its complications can have a significant impact on quality of life, longevity, and costs in public health. The World Health Organization (WHO) estimates that by 2040, 642 million people will suffer from diabetes, around 10% of the world adult population (WHO, 2015). Periodontal Diseases are considered the sixth complication of DM. This close relationship between both diseases is characterized by mutual influence. Thus, an appropriate control of periodontal disease may facilitate the DM control, improving quality of life on diabetic patients. Besides that, the presence of DM might impair prognosis of diverse dental treatments due to its inflammatory nature, negative influence on wound healing, on bone biology, and the establishment of infections. As a host modulatory therapy (HMT), the daily supplementation of omega-3 polyunsaturated fatty acids and low-dose aspirin has been proposed as adjunct therapy to the treatment of chronic periodontitis, showing good clinical and metabolic results in normoglycemic patients. Therefore, the aim of this study is to investigate the effectiveness of daily supplementation of omega-3 polyunsaturated fatty acids and low-dose aspirin as adjunct therapy to one-stage full-mouth periodontal ultrasonic debridement for the treatment of chronic periodontitis in type 2 diabetic patients through a superiority randomized clinical trial.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 75 Years

Eligibility

Inclusion Criteria:

• a) Age =35 b) diagnosis of type 2 DM for =5 years c) DM treatment with oral hypoglycemic agents or insulin supplementation and diet d) glycated hemoglobin (HbA1c) levels from 6.5% to 11% e) at least 15 teeth (excluding third molars and teeth indicated for extraction) f) moderate to severe generalized chronic periodontitis (Armitage, 1999) g) agree and sign the formal consent to participate in the study after receiving an explanation of risks and benefits from an individual who is not a member of the study (Resolution number 196 - October, 1996, and Ethics and Code of Professional Conduct in Dentistry - CFO179/93).

Exclusion Criteria:

• a) medical conditions that required prophylactic antimicrobial coverage b) scaling and root planing in the previous 6 months c) antimicrobial therapies in the previous 6 months d) anti-inflammatory therapies in the previous 6 months e) systemic conditions, other than DM, that could affect the progression of chronic periodontitis f) current use of medication that could interfere with periodontal response to treatment g) pregnancy or lactation h) smoking

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Periodontitis
• Diabetes Mellitus
• Periodontitis

Intervention

Drug:
• Placebo
One-stage full-mouth periodontal ultrasonic debridement plus placebo intervention
• 3g omega-3 plus 100mg aspirin daily for 60 days
Full-mouth periodontal debridement, 3g omega-3 plus 100mg aspirin daily for 60 days after periodontal therapy
• omega-3 plus aspirin before periodontal therapy
Full-mouth periodontal debridement, 3g omega-3 plus 100mg aspirin daily for 60 days before periodontal therapy

Locations

Country	Name	City	State
Brazil	UNESP	São José dos Campos	SP

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Estadual Paulista Júlio de Mesquita Filho	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

El-Sharkawy H, Aboelsaad N, Eliwa M, Darweesh M, Alshahat M, Kantarci A, Hasturk H, Van Dyke TE. Adjunctive treatment of chronic periodontitis with daily dietary supplementation with omega-3 Fatty acids and low-dose aspirin. J Periodontol. 2010 Nov;81(11) — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Glycated hemoglobin		Baseline, 180 days	No
Primary	Periodontal pockets with mean probing depth (PD) =5mm		Baseline, 90 days, 180 days	No
Secondary	Probing depth (mm)	Using a manual periodontal probe (North Carolina, HuFriedy, Chicago, IL, USA)	Baseline, 90 days, 180 days	No
Secondary	Clinical attachment level (mm)	Using a manual periodontal probe (North Carolina, HuFriedy, Chicago, IL, USA)	Baseline, 90 days, 180 days	No
Secondary	Gingival recession (mm)	Using a manual periodontal probe (North Carolina, HuFriedy, Chicago, IL, USA)	Baseline, 90 days, 180 days	No
Secondary	Bleeding on probing (%)	Using a manual periodontal probe (North Carolina, HuFriedy, Chicago, IL, USA)	Baseline, 90 days, 180 days	No
Secondary	Plaque index (%)	Using a manual periodontal probe (North Carolina, HuFriedy, Chicago, IL, USA)	Baseline, 90 days, 180 days	No